Catheter having a multilayered shaft section with a reinforcing mandrel

ABSTRACT

A catheter having an elongated shaft having at least a section which is multilayered with a first layer and a second layer secured to the first layer, and a mandrel having at least a section between the first and second layers. In one presently preferred embodiment, the mandrel is in contact with an outer surface of the first layer and with an inner surface of the second layer.

BACKGROUND OF THE INVENTION

This invention generally relates to catheters, and particularlyintravascular catheters for use in percutaneous transluminal coronaryangioplasty (PTCA) or for the delivery of stents.

In percutaneous transluminal coronary angioplasty (PTCA) procedures aguiding catheter is advanced in the patient's vasculature until thedistal tip of the guiding catheter is seated in the ostium of a desiredcoronary artery. A guidewire is first advanced out of the distal end ofthe guiding catheter into the patient's coronary artery until the distalend of the guidewire crosses a lesion to be dilated. A dilatationcatheter, having an inflatable balloon on the distal portion thereof, isadvanced into the patient's coronary anatomy over the previouslyintroduced guidewire until the balloon of the dilatation catheter isproperly positioned across the lesion. Once properly positioned, thedilatation balloon is inflated with inflation fluid one or more times toa predetermined size at relatively high pressures so that the stenosisis compressed against the arterial wall and the wall expanded to open upthe vascular passageway. Generally, the inflated diameter of the balloonis approximately the same diameter as the native diameter of the bodylumen being dilated so as to complete the dilatation but not overexpandthe artery wall. After the balloon is finally deflated, blood flowresumes through the dilated artery and the dilatation catheter and theguidewire can be removed therefrom.

In such angioplasty procedures, there may be restenosis of the artery,i.e. reformation of the arterial blockage, which necessitates eitheranother angioplasty procedure, or some other method of repairing orstrengthening the dilated area. To reduce the restenosis rate ofangioplasty alone and to strengthen the dilated area, physicians nownormally implant an intravascular prosthesis, generally called a stent,inside the artery at the site of the lesion. Stents may also be used torepair vessels having an intimal flap or dissection or to generallystrengthen a weakened section of a vessel or to maintain its patency.Stents are usually delivered to a desired location within a coronaryartery in a contracted condition on a balloon of a catheter which issimilar in many respects to a balloon angioplasty catheter, and expandedwithin the patient's artery to a larger diameter by expansion of theballoon. The balloon is deflated to remove the catheter and the stentleft in place within the artery at the site of the dilated lesion. Seefor example, U.S. Pat. No. 5,507,768 (Lau et al.) and U.S. Pat. No.5,458,615 (Klemm et al), which are incorporated herein by reference.

An essential step in effectively performing a PTCA procedure is properlypositioning the balloon catheter at a desired location within thecoronary artery. To properly position the balloon at the stenosedregion, the catheter shaft must be able to transmit force along thelength of the catheter shaft to allow it to be pushed through thevasculature. However, the catheter shaft must also retain sufficientflexibility to allow it to track over a guidewire through the oftentortuous vasculature. Additionally, the catheter also must be able tocross stenosed portions of the vascular anatomy. To help meet the desirefor a catheter having sufficient pushability and crossability, whilemaintaining trackability, prior art designs have supplemented polymercatheter shafts with a stiffening wire or mandrel. Other prior artdesigns have addressed these handling and performance issues by usingmaterials of different stiffness for the proximal and distal sections ofthe catheter. To prevent kinking at the junction between the proximaland distal sections, while maintaining trackability and pushability,some conventional designs have employed a stiffening wire to bridge thetransition in catheter shaft material. Despite these attempts, prior artdesigns have suffered from various drawbacks. For example, supportmandrels do not always transmit axial force effectively.

Accordingly, it would be a significant advance to provide a catheterhaving improved pushability and crossability while maintaining goodtrackability. This invention satisfies these and other needs.

SUMMARY OF THE INVENTION

The invention is directed to a catheter having an elongated shaft havingat least a section which is multilayered with a first layer and a secondlayer secured to the first layer, and a mandrel having at least asection between the first and second layers. In one presently preferredembodiment, the mandrel is in contact with an outer surface of the firstlayer and with an inner surface of the second layer.

In a presently preferred embodiment, the multilayered section of theshaft with the first and second layers is a proximal shaft section. Inone embodiment, the first layer has a distal end located proximal to thedistal end of the second layer, and the shaft has a distal shaft sectioncomprising a distal section of the second layer extending beyond thefirst layer distal end. The multilayered proximal shaft section istypically about 50 to about 80% of the length of the catheter shaft. Ina presently preferred embodiment, the section of the mandrel between thefirst and second layers is a proximal section, so that the mandrel has aproximal section secured between and in contact with the first andsecond layers from the proximal to the distal end of the first layer,and a distal section extending beyond the distal end of the first layer.The distal section of the mandrel extending beyond the distal end of thefirst layer is typically about 10 to about 40%, preferably about 20 toabout 30% of the mandrel length. Alternatively, the mandrel has a distalend section located between and in contact with the first and secondlayers, so that in one embodiment, the entire length or at leastsubstantially all of the length of the mandrel is located between thefirst and the second layers. With the reinforcing mandrel securedbetween the first and second layers and optionally extending beyond theend of the first layer, the catheter shaft provides improved pushabilityand kink resistance. Preferably, the catheter distal shaft section isrelatively flexible and soft and the proximal shaft section isrelatively stiff and pushable, without requiring separate longitudinalsegments joined together. Thus, it should be understood that theproximal shaft section and the distal shaft section may be formed of aunitary, one piece tubular member, as for example in the embodiment inwhich the shaft comprises a multilayered proximal shaft section formedof the first layer secured to a surface of the second layer, and adistal shaft section formed of the portion of the second layer whichextends beyond the distal end of the first layer. Consequently, thecatheter of the invention has excellent pushability, trackability, andmanufacturability, and preferably without external or internal junctionsbetween longitudinal segments.

In a presently preferred embodiment, the catheter is a balloon catheter.The balloon catheter of the invention may comprise a variety of suitableballoon catheters, including coronary and peripheral dilatationcatheters, stent delivery catheters, drug delivery catheters, and thelike. A balloon catheter of the invention generally comprises anelongated shaft having a proximal shaft section, a distal shaft section,an inflation lumen extending within the proximal and distal shaftsections, and a guidewire receiving lumen having at least a portionextending within the distal shaft section, and an inflatable balloon onthe distal shaft section with an interior in fluid communication withthe inflation lumen. In a presently preferred embodiment, an innertubular member defines the guidewire lumen, and an outer tubular memberdefines the inflation lumen, and the outer tubular member is the part ofthe shaft having at least a section which is multilayered.

In a presently preferred embodiment, the balloon catheter is anover-the-wire type catheter having a guidewire proximal port at theproximal end of the catheter shaft, a guidewire distal port at thedistal end of the catheter shaft, and a guidewire lumen extendingbetween the guidewire ports from the proximal to the distal end of thecatheter shaft. In an alternative embodiment, the catheter is a rapidexchange type catheter having a guidewire proximal port in the distalshaft section spaced a relatively short distance proximally from theguidewire distal port and a relatively long distance from the proximalend of the catheter shaft, a guidewire distal port at the distal end ofthe catheter, and a relatively short guidewire lumen extending betweenthe proximal and distal guidewire ports in the distal shaft section.

In a presently preferred embodiment, the reinforcing mandrel is anelongated, solid member formed of a metal such as a stainless steel.However, a variety of suitable high strength materials may be used suchas a nickel-titanium (Nitinol) alloy, MP35N, and Elgiloy, and includingpolymeric materials such as polyetheretherketone (PEEK), polyamides, andreinforced polymers, or other suitable high strength materials fromwhich a small diameter member can be readily formed. The mandreltypically tapers distally to a smaller outer dimension, with a graduallytapering outer diameter or one or more tapered sections intermittentlylocated between nontapered sections. The reinforcing mandrel can have avariety of suitable transverse cross sectional shapes along all or partof the length thereof, including circular, oblong, square, andrectangular, and is typically a wire, or a ribbon with a flat transversecross sectional shape.

The catheter of the invention is highly pushable, flexible, trackableand kink resistant due to the reinforcing mandrel secured between thefirst and second layers of the shaft. The shaft of the inventionprovides an improved transition between the proximal shaft section andthe more flexible distal shaft section, for improved kink resistance.Thus, the flexible and pushable shaft provides a catheter with excellenttrackability, and allows easy advancement over a guidewire andmaneuvering within the patient's tortuous anatomy, to position theoperative portion of the catheter at a desired location within thepatient. These and other advantages of the invention will become moreapparent from the following detailed description of the invention andthe accompanying exemplary drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is an elevational view, partially in section, of a ballooncatheter which embodies features of the invention.

FIG. 2 is a transverse cross sectional view of the catheter shown inFIG. 1, taken along line 2-2.

FIG. 3 is a transverse cross sectional view of the catheter shown inFIG. 1, taken along line 3-3.

FIG. 4 is a transverse cross sectional view of the catheter shown inFIG. 1, taken along line 4-4.

FIG. 5 is a transverse cross sectional view of the catheter shown inFIG. 1, taken along line 5-5.

FIG. 6 is a longitudinal cross sectional view illustrating the innerlayer of the outer tubular member of the catheter of FIG. 1, duringmanufacturing of the shaft before the outer layer is positioned on theinner layer, with the reinforcing mandrel in a groove in the innerlayer.

FIG. 7 is a transverse cross sectional view of the inner layer shown inFIG. 6, taken along line 7-7.

DETAILED DESCRIPTION OF THE INVENTION

FIG. 1 illustrates an over-the-wire balloon catheter 10 embodyingfeatures of the invention. Catheter 10 generally comprises an elongatedcatheter shaft 11 having a proximal end, a distal end, a proximal shaftsection 12, a distal shaft section 13, an outer tubular member 14, andan inner tubular member 15. Inner tubular member 15 defines a guidewirelumen 16 adapted to slidingly receive a guidewire 17. The coaxialrelationship between outer tubular member 14 and inner tubular member 15defines annular inflation lumen 18, as best shown in FIGS. 2-4,illustrating transverse cross sections of the catheter of FIG. 1, takenalong lines 2-2, 3-3 and 4-4, respectively. An inflatable balloon 19 isdisposed on the distal shaft section 13, having a proximal skirt sectionsealingly secured to the distal end of outer tubular member 14, and adistal skirt section sealingly secured to the distal end of innertubular member 15, so that its interior is in fluid communication withinflation lumen 18. An adapter 20 at the proximal end of the shaft isconfigured to provide access to guidewire lumen 16, and to directinflation fluid through arm 21 into inflation lumen 18. FIG. 1illustrates the balloon 19 prior to complete inflation, with anexpandable stent 30 mounted on a working length of the balloon. Thedistal end of the catheter may be advanced to a desired region of apatient's body lumen in a conventional manner, and balloon 19 inflatedto expand stent 30, and the balloon deflated, leaving stent 30 implantedin the body lumen. FIG. 5 illustrates a transverse cross section of thecatheter of FIG. 1, taken along line 5-5.

In the embodiment illustrated in FIG. 1, the outer tubular member 14 hasa multilayered proximal shaft section 33, and a distal shaft section 34.The multilayered proximal shaft section 33 of the outer tubular member14 has a first polymeric layer 35, and a second polymeric layer 36coaxially disposed around and secured to the first layer 35. The distalend of the first layer 35 is located proximal to the distal end of thesecond layer 36, so that the distal shaft section 34 of the outertubular member 14 is formed by a distal section of the second layer 36extending beyond the distal end of the first layer 35, i.e., a one-piecetubular member forms the outer layer 36 of the outer tubular memberproximal section 33 and the entire distal section 34 of the outertubular member 14 in the embodiment of FIG. 1. The first and secondlayers 35, 36 are secured together along at least a substantial lengthof, and typically the entire length of, the first layer 35, as forexample by heat fusion bonding or adhesive bonding the layers together.

In the embodiment illustrated in FIG. 1, the distal end of the firstlayer 35 is truncated with a tapering wedge-like shape. The truncateddistal end section of the first layer 35 is located at a tapered section37 of the outer tubular member 14. Specifically, in the embodiment ofFIG. 1, the truncated distal end of the first layer 35 has a proximalend at the proximal end of the tapered section 37 of the outer tubularmember 14 and a distal end located proximal to the distal end of thetapered section 37 of the outer tubular member 14. The truncated distalend of the first layer 35, extending at an angle distally, provides animproved transition between the relatively stiff proximal section 12 andthe relatively flexible distal section 13 of the shaft 11, to reducekinking. The truncated distal end of the first layer 35 is typicallyabout 20 cm to about 35 cm, preferably about 25 cm to about 35 cm inlength. The tapered section 37 of the outer tubular member 14 typicallyhas a length of about 4 inches to about 6 inches, along which the outertubular member 14 tapers from an outer diameter of about 0.042 to about0.046 inches (0.11 to 0.12 cm), to an outer diameter of about 0.031 toabout 0.036 inches (0.08 to 0.09 cm).

In the embodiment of FIG. 1, the second layer 36 of the multilayeredproximal section 33 (and the distal section 34) of the outer tubularmember 14 is preferably formed of a polyamide such as polyether blockamide (PEBAX), and more specifically PEBAX 72D (having a Shore durometerhardness of about 72D), available from Autochem. However a variety ofsuitable polymers may be used including nylons such as nylon 12 and L20,and including other grades of PEBAX having a Shore durometer hardnesslower than that of PEBAX 72D, such as PEBAX 63D. The PEBAX tubularmember forming the second layer 36 of the outer tubular membermultilayered proximal section 33, and the outer tubular member distalsection 34 is typically formed by extrusion and necking, resulting in aone-piece tapered PEBAX tubular member. The first layer 35 of themultilayered proximal section 33 is preferably formed of a polymericmaterial having a higher Shore Durometer hardness than the one-piecetapered PEBAX tubular member (i.e., the second layer 36 of the outertubular member proximal section 33, and the outer tubular member distalsection 34), to provide a relatively stiff proximal shaft section 12.The first layer 35 of the multilayered proximal section 33 of the outertubular member 14 is preferably formed of a high strength polymer suchas polyetheretherketone (PEEK), however a variety of suitable polymersmay be used including polyamide, reinforced polymers. The PEEK istypically plasma treated to facilitate fusing the first layer 35 to thesecond layer 36. Additionally, in the embodiment of FIG. 1, the firstlayer 35 of the multilayered proximal section 33 has a greater wallthickness than the one-piece tapered PEBAX tubular member, to furtherincrease the stiffness of the proximal shaft section 12 relative to thedistal shaft section 13. In one embodiment, the first layer 35 of themultilayered proximal section 33 has a wall thickness of about 0.003 toabout 0.004 inches (0.008 to 0.01 cm), and the second layer 36 of themultilayered proximal section 33 has a wall thickness of about 0.002 toabout 0.003 inches (0.005 to 0.008 cm), and the distal section 34 of theouter tubular member 14 has a wall thickness of about 0.005 to about0.006 inches (0.013 to 0.015 cm).

In the embodiment of the FIG. 1, a mandrel 40 has a proximal section 41secured between and in contact with the first and second layers 35, 36of the multilayered proximal section 33 of the outer tubular member 14,and a distal section 42 extending beyond the distal end of the firstlayer 35. The proximal section 41 of the mandrel 40 is in contact withan outer surface of the first layer 35 and in inner surface of thesecond layer 36. Thus, a portion of the first layer 35 is separated froma portion of the outer layer 36 by the mandrel 40. In an alternativeembodiment (not shown), the first layer 35 of the outer tubular membermultilayered proximal section 33 is on an outer surface of the secondlayer 36, so that the mandrel 40 is in contact with an outer surface ofthe second layer 36 and in inner surface of the first layer 35. Thedistal section 42 of the mandrel 40 is within the inflation lumen 18. Ina presently preferred embodiment, the distal section 42 of the mandrel40 is not secured to the shaft 12, and is thus free within the inflationlumen 18 between the distal section of the inner tubular member and thedistal section of the outer tubular member 14, for improved flexibilityand kink resistance. However, at least a portion of the distal section42 of the mandrel 40 may alternatively be secured to the distal section34 of the outer tubular member 14, as for example by adhesive bonding.The proximal end of the mandrel is typically secured, for example by anadhesive, to the proximal adapter 20. In the embodiment illustrated inFIG. 1, the distal end of the mandrel 40 is proximal to the proximalskirt section of the balloon 19. However, in alternative embodiments(not shown), the distal end may be located distal to the proximal skirtsection of the balloon 19, for example at the radiopaque markers on theshaft or at the distal end of the balloon interior.

The mandrel 40 typically has a length of about 100 to about 143 cm,preferably about 106 to about 135 cm, depending on the length of thecatheter, so that the mandrel length is typically about 70 to about100%, preferably about 85 to about 90% of the length of the shaft 11.The mandrel 40 typically tapers distally to a smaller outer diameter. Inone embodiment, the mandrel 40 has a proximal portion with a constantouter transverse dimension or diameter of about 0.015 to about 0.018inches (0.38 to 0.46 mm), a proximal tapered portion tapering distallyto a smaller outer transverse dimension of about 0.006 to about 0.009inches (0.15 to 0.23 mm), and a distal tapered portion tapering distallyto a smaller outer transverse dimension of about 0.002 to about 0.003inches. (0.05 to 0.08 mm), for a mandrel with a circular transverseshape. The mandrel 40 preferably has an outer transverse dimension whichis less than the wall thickness of the first layer 35 of the outertubular member proximal section 33, and greater than the wall thicknessof the second layer 36 of the outer tubular member proximal section 33.The size of the mandrel diameter or transverse dimension relative to thewall thickness of the layers 35, 36 will depend on whether the mandrelhas a circular, oblong, or other transverse shape. In one embodiment,the mandrel 40 outer transverse dimension is about 10 to about 20% lessthan the wall thickness of the first layer 35, and about 10 to about 20%greater than the wall thickness of the second layer 36.

The mandrel 40 is in contact with both the first layer 35 and the secondlayer 36 of the outer tubular member proximal section 33. The mandrel 40is thus partially encased in the first layer 35, and a perimeter orcircumference of the mandrel 40 has a first portion in contact with thefirst layer 3 5 and a second portion in contact with the second layer36. Typically, about 75% to about 90% of the circumference of themandrel 40 is in contact with the first layer 35, and about 10% to about25% of the circumference of the mandrel is in contact with the secondlayer 36. In the embodiment illustrated in FIG. 2, about 80% to about90% of the circumference of the mandrel 40 is in contact with the firstpolymeric layer 35, and about 10% to about 20% of the circumference ofthe mandrel is in contact with the second polymeric layer 36.

The mandrel 40 has at least a body or core which is preferably formed ofstainless steel, such as L605. The stainless steel is typically fullhard or spring tempered. However, a variety of suitable materials may beused including other ferrous materials such as Nitinol, or non-ferrousmaterials. In the embodiment of FIG. 1, the body of the mandrel 40 isformed of a solid metal wire. The body of the mandrel 40 may be providedwith a coating or outer layer along at least a section thereof. In oneembodiment (not shown), the proximal section 41 of the mandrel 40 has anoblong transverse cross section, while the distal section 42 has acircular transverse cross section.

FIG. 6 illustrates one embodiment of a polymeric tube which will formthe first layer 35 of the outer tubular member proximal section 33 ofthe catheter of FIG. 1, during assembly of the catheter 10 before thesecond layer 36 is secured thereto, in one embodiment of a method offorming a catheter shaft which embodies features of the invention. Inthe embodiment illustrated in FIG. 6, the first layer 35 has a groove inan outer surface configured to receive the mandrel 40 therein. Thegroove has a semi-circular transverse cross section. The groove ispreferably formed in the outer surface of the first layer 35 duringextrusion of the tubular member forming the first layer 35, although itmay alternatively be formed after the extrusion of the tubular memberforming first layer 35, as for example by cutting or otherwise removingmaterial from the outer surface of the first layer 35. In the embodimentillustrated in FIG. 6, the depth of the groove is about equal to thetransverse dimension of the mandrel 40, so that the mandrel outersurface is aligned with (i.e., flush with) the outer surface of thefirst layer on either side of the groove. However, in an alternativeembodiment (not shown), the groove is shallower than the mandrel so thatthe mandrel outer surface extends outside of the groove above the outersurface of the tube which will form the first layer 35.

During assembly of the catheter, the first layer 35, with the mandrel inthe groove, is positioned in the lumen of the tubular member which formsthe second layer 36. Specifically, the one-piece tubular member, whichforms both the second layer 36 of the outer tubular member proximalsection 33 and the outer tubular member distal section 34, is positionedaround the first layer 35 (and the mandrel 40) so that the proximalsection of the one-piece tubular member is surrounding the first layer35. The second layer 36 is then secured to an outer surface of the firstlayer 35 as, for example, by fusing by heating during a hot air neckingprocess with shrink tubing therearound. The shrink tubing is thenremoved, leaving the first and second layers 35, 36 fused together, withthe proximal section 41 of the mandrel 40 secured between the first andsecond layers 35, 36.

To the extent not previously discussed herein, the various cathetercomponents may be formed and joined by conventional materials andmethods. For example, inner tubular member 15 can be formed byconventional techniques, such as by extruding and necking materialsfound useful in intravascular catheters such a polyethylene, polyvinylchloride, polyesters, polyamides, polyimides, polyurethanes, andcomposite materials, and is preferably a multilayered tubular member.Additionally, although not illustrated, coiled or braided reinforcementsmay be included in the shaft at various locations, as is conventionallyknown.

The length of the dilatation catheter 10 is generally about 108 to about200 centimeters, preferably about 137 to about 145 centimeters, andtypically about 140 centimeters for PTCA. The outer tubular member 14distal section has an outer diameter (OD) of about 0.028 to about 0.036inch (0.70-0.91 mm), and an inner diameter (ID) of about 0.024 to about0.035 inch (0.60-0.89 mm), and the outer tubular member 14 proximalsection has an OD of about 0.017 to about 0.034 inch (0.43-0.87 mm), andan inner diameter (ID) of about 0.012 to about 0.022 inch (0.30-0.56mm). The inner tubular member 15 has an OD of about 0.017 to about 0.026inch (0.43-0.66 mm), and an ID of about 0.015 to about 0.018 inch(0.38-0.46 mm) depending on the diameter of the guidewire to be usedwith the catheter. The balloon 19 has a length of about 14 mm to about46 mm, and an inflated working diameter of about 8 mm to about 40 mm.

While the present invention has been described herein in terms ofcertain preferred embodiments, those skilled in the art will recognizethat modifications and improvements may be made without departing formthe scope of the invention. For example, although the catheter 10illustrated in the Figures is an over-the-wire balloon catheter, thecatheter of the invention may be a variety of suitable catheters,including other balloon catheter configurations, guiding catheters, andthe like. Additionally, although the mandrel 40 is illustrated as partof an outer tubular member in the Figures, the mandrel 40 couldalternatively be part of a multilayered inner tubular member or othershaft configuration. While individual features of one embodiment of theinvention may be discussed or shown in the drawings of the oneembodiment and not in other embodiments, it should be apparent thatindividual features of one embodiment may be combined with one or morefeatures of another embodiment or features from a plurality ofembodiments.

1. An intraluminal catheter, comprising: a) an elongated shaft having aproximal end, a distal end, at least one lumen therein, and at least asection which is multilayered with a first polymeric layer and a secondpolymeric layer secured to the first polymeric layer; and b) a mandrelhaving at least a section between the first and second polymeric layersof the multilayered section.
 2. The catheter of claim 1 wherein thesection of the mandrel between the first and second polymeric layers isin contact with an outer surface of the first polymeric layer and aninner surface of the second polymeric layer.
 3. The catheter of claim 1wherein the multilayered section with the first and second polymericlayers is a proximal shaft section.
 4. The catheter of claim 3 whereinthe multilayered proximal shaft section is about 50 to about 80% of thelength of the shaft.
 5. The catheter of claim 3 wherein the secondpolymeric layer has a distal end located distal to the distal end of thefirst polymeric layer, so that the second layer has a proximal sectionextending along the multilayered proximal shaft section and a distalsection extending beyond the distal end of the multilayered proximalshaft section to at least in part form a distal shaft section of theshaft.
 6. The catheter of claim 5 wherein the shaft includes a taperedsection with a diameter tapering distally to a smaller diameter, formedat least in part by the multilayered proximal shaft section and thedistal section of the second polymeric layer.
 7. The catheter of claim 5wherein the distal end of the first polymeric layer is truncated.
 8. Thecatheter of claim 7 wherein the truncated distal end of the firstpolymeric layer is located at least in part between a proximal and adistal end of the tapered section of the second polymeric layer.
 9. Thecatheter of claim 1 wherein the first polymeric layer is formed ofpolyetheretherketone, and the second polymeric layer is formed of apolyether block amide.
 10. The catheter of claim 1 wherein the mandrelhas a distal end located between and in contact with the first andsecond polymeric layers.
 11. The catheter of claim 5 wherein the sectionof the mandrel between the first and second polymeric layers is aproximal section secured between the first and second polymeric layersfrom the proximal to the distal end of the first polymeric layer, andthe mandrel has a distal section extending beyond the distal end of thefirst polymeric layer.
 12. The catheter of claim 11 wherein the distalsection of the mandrel is within the at least one lumen of the shaft andis not secured to the second polymeric layer.
 13. The catheter of claim11 wherein the distal section of the mandrel is about 20 to about 35% ofthe mandrel length.
 14. The catheter of claim 11 wherein the proximalsection of the mandrel has an oblong transverse cross section, and thedistal section of the mandrel has a circular transverse cross section.15. The catheter of claim 1 wherein the section of the mandrel betweenthe first and second polymeric layers has a circumference, and about 75to about 90% of the circumference of the mandrel is in contact with thefirst polymeric layer and about 10 to about 25% of the circumference ofthe mandrel is in contact with the second polymeric layer.
 16. Thecatheter of claim 1 wherein the mandrel is a solid walled member formedof a material selected from the group consisting of a metallic material,and a polymeric material.
 17. The catheter of claim 1 wherein themandrel has an outer transverse dimension which is about 10 to about 20%less than a wall thickness of the first polymeric layer.
 18. Thecatheter of claim 1 wherein the mandrel has an outer transversedimension which is about 10 to about 20% greater than a wall thicknessof the second polymeric layer.
 19. The catheter of claim 1 wherein thelength of the mandrel has a length which is about 75 to about 100% ofthe shaft length.
 20. The catheter of claim 1 wherein the catheter is aballoon catheter having a balloon on a distal shaft section with aninterior in fluid communication with the at least one lumen of theshaft. 21-28. (canceled)
 29. A method of making a catheter having anelongated shaft and a reinforcing mandrel, comprising: a) positioning areinforcing mandrel within a groove in an outer surface of a firsttubular member; b) securing a proximal section of a second tubularmember to the outer surface of the first tubular member, so that themandrel has a proximal section located between the first and secondtubular members and a distal section located within a lumen of thesecond tubular member and distal to a distal end of the first tubularmember.
 30. The catheter of claim 1 wherein the multilayered section isa proximal section with the first and second polymeric layers, and theshaft includes a distal section formed of a distal portion of the secondpolymeric layer extending beyond a distal end of the first polymericlayer and with an inner surface defining a lumen in the shaft distalsection.
 31. The catheter of claim 1 where the first layer has a groovein an outer surface thereof with the mandrel therein.